Cleared Abbreviated

K200633 - Halyard Black-Fire Powder-Free Nitrile ...

K200633 is the FDA 510(k) clearance for Halyard Black-Fire Powder-Free Nitrile ... by 0 & M Halyard, Inc.. It is a Class 1 General Hospital device (product code LZC) cleared through the Abbreviated 510(k) pathway after a 215-day FDA review.

K200633 · 0 & M Halyard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
215d
Days
Class 1
Risk

K200633 is an FDA 510(k) clearance for the Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by 0 & M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on October 11, 2020 after a review of 215 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all 0 & M Halyard, Inc. devices

Submission Details

510(k) Number K200633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2020
Decision Date October 11, 2020
Days to Decision 215 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 129d · This submission: 215d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZC Medical Glove, Specialty

All 40
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K200633.
AspenMed+
K213076 · Aspen Glove Sdn. Bhd. · Dec 2021
Disposable Medical Nitrile Examination Gloves (Non sterile)
K212639 · Jiangsu Nanfang Medical Co., Ltd. · Dec 2021
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
K212827 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Dec 2021
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
K201390 · Medline Industires, Inc. · Sep 2020
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
K193555 · Ever Global (Vietnam) Enterprise Corp · Jun 2020
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
K191230 · O&M Halyard, Inc. · Nov 2019